MAUDE Adverse Event Report: SEASPINE INC. MARINER PEDICLE SCREW SYSTEM; SET SCREW

Model Number 41-1010

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

The 41-1010 set screws were not returned for analysis; however, based on the x-ray provided and visual analysis, the product monitoring team and engineering were able to confirm two set screws disassociated from the screw heads postoperatively.Of note, there appears to have been trauma at l2.The distributor confirmed two set screws were waisted/discarded due to cross-threading upon insertion.The screw heads were likely damaged or stripped as well as a result of the set screw cross-threading.Based on the x-ray provided, the rod orientation suggests there may have been a large reduction force required to manipulate the rod's placement.Depending on the surgical technique, this maneuver could have potentially caused damage to the implants as well and can also be considered a contributing factor to the postoperative separation that is depicted.Based on the information available, several implants were stripped and damaged upon initial insertion and therefore required replacement.Additionally, the x-ray provided indicates the rod has moved significantly from the screw heads, providing evidence there were high loads required to seat them at the time of initial insertion.This evidence indicates difficulty in placing the implants in order to achieve the trauma decompression performed.These complex loads and maneuvers along with the patient's condition most likely contributed to the reported postoperative disassociation.

Event Description

On 28 may 2020, seaspine was made aware of a mariner pedicle screw system postoperative implant failure.The index surgery was performed on (b)(6) 2020 and the revision surgery took place approximately two weeks later, which consisted of removing the seaspine hardware and replacing with an alternative company's hardware.The event was discovered as a result of a follow up appointment where the patient reported pain and feeling something in their back under the incision site.Plain-films confirmed two set screws on the right side of the construct had separated from the screw heads.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SET SCREW
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer (Section G): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• Manufacturer Contact: audrey mudderman ; 5770 armada drive; carlsbad, ca ; 2165137
• MDR Report Key: 10182245
• MDR Text Key: 199250822
• Report Number: 3012120772-2020-00041
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10889981155100
• UDI-Public: 10889981155100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41-1010
• Device Catalogue Number: 41-1010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention